USPTO Patents Application 09581402

United States Patent and Trademark Office

UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark GfTlce

Address: COMMISSIONER FOR PATENTS
P.O. Box 1450

Alexandria, Virginia 223 13-1450
www.uspto.gov

APPLICATION NO.

FILING DATE

FIRST NAMED INVENTOR

ATTORNEY DOCKET NO

CONFIRMATION NO.

09/581,402

06/12/2000

7590

12/08/2003

WENDEROTH LIND & PONACK
2033 K STREET NW
SUITE 800

WASHINGTON, DC 20006

TETSUNORI FUJISAWA

2000_0562A

7196

EXAMINER

FREDMAN, JEFFREY NORMAN

ART UNIT

PAPER NUMBER

1634

DATE MAILED: 12/08/2003

Please find below and/or attached an Office communication concerning this application or proceeding.

PTO-90C (Rev. 10/03)

Office Action Summary

Application No.

09/581,402

Applicant(s)

FUJISAWA ETAL

Examiner

Jeffrey Fredman

Art Unit

1634

" The MAILING DATE of this communication appears on the cover sheet with the correspondence address-
Period for Reply

A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE 1 MONTH(S) FROM
THE MAILING DATE OF THIS COMMUNICATION.

- Extensions of time may be available under the provisions of 37 CFR 1 .136(a). In no event, however, may a reply be timely filed
after SIX (6) MONTHS from the mailing date of this communication.

- If the period for reply specified above is less than thirty (30) days, a reply within the statutory minimum of thirty (30) days will be considered timely.

- If NO period for reply is specified above, the maximum statutory period v^fill apply and will expire SIX (6) MOr4THS from the mailing date of this communication.

- Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 133).

- Any reply received by the Office later than three months after the mailing date of this communication, even if timely filed, may reduce any
earned patent term adjustment. See 37 CFR 1.704(b).

Status

1 )M Responsive to communication(s) filed on 14 October 2003 .
2a)n This action is FINAL. 2b)!3 This action is non-fmal.

3) n Since this application is in condition for allowance except for formal matters, prosecution as to the merits is

closed in accordance with the practice under £x parte Quayle, 1935 CD. 11, 453 O.G. 213.

Disposition of Claims

4) 13 Claim(s) 23-28 is/are pending in the application.

4a) Of the above claim(s) is/are withdrawn from consideration,

5) n Claim(s) is/are allowed.

6) 0 Claim(s) is/are rejected.

/)□ Claim(s) is/are objected to.

8) 13 Clalm(s) 23-28 are subject to restriction and/or election requirement.
Application Papers

9) 0 The specification is objected to by the Examiner.

10) 0 The drawing(s) filed on is/are: 3)0 accepted or b)^ objected to by the Examiner.

Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121(d).

1 1) 0 The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PTO-152.
Priority under 35 U.S.C. §§119 and 120

12) 0 Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).

a)nAII b)n Some*c)n None of:

1 .□ Certified copies of the priority documents have been received.

2. n Certified copies of the priority documents have been received in Application No. .

3. n Copies of the certified copies of the priority documents have been received in this National Stage

application from the International Bureau (PCT Rule 17.2(a)).
* See the attached detailed Office action for a list of the certified copies not received.

13) 0 Acknowledgment is made of a claim for domestic priority under 35 U.S.C. § 119(e) (to a provisional application)

since a specific reference was included in the first sentence of the specification or in an Application Data Sheet.
37 CFR 1.78.

a) □ The translation of the foreign language provisional application has been received.

14) D Acknowledgment is made of a claim for domestic priority under 35 U.S.C. §§ 120 and/or 121 since a specific

reference was included in the first sentence of the specification or in an Applicafion Data Sheet. 37 CFR 1.78.

Attach ment(s)

1) n Notice of References Cited (PTO-892) 4) □ Interview Summary (PTO-413) Paper No(s). .

2) n Notice of Draftsperson's Patent Drawing Review (PTO-948) 5) [I] Notice of Informal Patent Application (PTO-152)

3) D infornnation Disclosure Statement(s) (PTO-1449) Paper No(s) . 6) D Other:

U.S. Patent and Trademark Office
PTOL-326 (Rev. 11-03)

Office Action Summary

Part of Paper No. 20031202

Application/Control Number: 09/581,402 Page 2

Art Unit: 1634

DETAILED ACTION
Status

In view of tlie new claims, which are drawn to new groups, a restriction
requirement is necessary. Upon election, the next action will be a Final action, since
this restriction and the subsequent action are necessitated by Applicant's amendment.

Election/Restrictions

1. Restriction to one of the following inventions is required under 35 U.S. C. 121:
Groups 1 -34 Claims 23-25, drawn to enzyme Inhibitor compounds,

classified in class 435, subclass 69.2, where each separate
compound in claims 23-25 represents a different group.
Groups 35-68 Claims 26-28, drawn to methods of disease treatment,
classified in class 514, subclass 1, where each separate
compound in claims 23-25 represents a different group.
The inventions are distinct, each from the other because of the following reasons:

2. Inventions in Groups 1-34 and in Groups 35-68 are related as product and
process of use. The inventions can be shown to be distinct if either or both of the
following can be shown: (1) the process for using the product as claimed can be
practiced with another materially different product or (2) the product as claimed can be
used in a materially different process of using that product (MPEP § 806.05(h)). In the
Instant case, the products can be used for treatment methods as in Groups 35-68, in
enzymatic assay methods or in purification of matrix metalloproteinase assay methods.

Application/Control Number: 09/581,402 Page 3

Art Unit: 1634

3. Inventions in Groups 1 -68 are also related as different matrix metalloprotelnase
inhibitors. Each of these compounds is structurally distinct from one another, without a
shared core structure. For example, the first compound comprises an acetimidoyl-L-
lysine group while the second compound comprises a aminomethyl-L-phenylaianine
compound. These share no common structural features other than the additional
groups linked to the substructures. This is even more clearly seen by comparing other
group members, some of which further differentiate the structure by having
methylsuccinyl or 3-(m-carboxyphenyl)propylsuccinyl groups linked to the base
structure. Thus, each inhibitor is distinct, would require a distinct search and lacks any
common core structure.

Should applicant traverse on the ground that the Groups are not patentably
distinct, applicant should submit evidence or identify such evidence now of record
showing that each Group is an obvious variants or clearly admit on the record that this
is the case. In either instance, if the examiner finds one of the inventions unpatentable
over the prior art, the evidence or admission may be used in a rejection under 35
U.S.C. 103(a) of the other invention. The central question in this restriction is whether
these compounds are obvious one over another, such that if one compound was issued,
would a double patenting rejection be appropriate over the other compounds. Currently,
there is no evidence or admission that these are obvious variants on the record, so that
such a double patenting rejection would currently be inappropriate.
4. Because these inventions are distinct for the reasons given above and have
acquired a separate status in the art as shown by their different classification, restriction

Application/Control Number: 09/581 ,402 Page 4

Art Unit: 1634

for examination purposes as indicated is proper. Also, because these inventions are
distinct for the reasons given above and the search required for each Group is distinct,
restriction for examination purposes as indicated is proper.

5. A telephone call was made to Warren Cheek on December 2, 2003 to request an
oral election to the above restriction requirement, but did not result in an election being
made.

Applicant is advised that the reply to this requirement to be complete must
include an election of the invention to be examined even though the requirement be
traversed (37 CFR 1.143).

6. Applicant is reminded that upon the cancellation of claims to a non-elected
invention, the inventorship must be amended in compliance with 37 CFR 1 .48(b) if one
or more of the currently named inventors is no longer an inventor of at least one claim
remaining in the application. Any amendment of inventorship must be accompanied by
a request under 37 CFR 1 .48(b) and by the fee required under 37 CFR 1 .17(1).

7. The examiner has required restriction between product and process claims.
Where applicant elects claims directed to the product, and a product claim is
subsequently found allowable, withdrawn process claims that depend from or otherwise
include all the limitations of the allowable product claim will be rejoined in accordance
with the provisions of MPEP § 821 .04. Process claims that depend from or
otherwise include all the limitations of the patentable product will be entered as a
matter of right if the amendment is presented prior to final rejection or allowance,

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Art Unit: 1634

whichever is earlier. Amendments submitted after final rejection are governed by 37
CFR 1.116; amendments submitted after allowance are governed by 37 CFR 1 .312.

In the event of rejoinder, the requirement for restriction between the product
claims and the rejoined process claims will be withdrawn, and the rejoined process
claims will be fully examined for patentability in accordance with 37 CFR 1 .104. Thus, to
be allowable, the rejoined claims must meet all criteria for patentability including the
requirements of 35 U.S.C. 101, 102, 103, and 112. Until an elected product claim is
found allowable, an otherwise proper restriction requirement between product claims
and process claims may be maintained. Withdrawn process claims that are not
commensurate in scope with an allowed product claim will not be rejoined. See
"Guidance on Treatment of Product and Process Claims in light of In re Ochiai, In re
Brouwer an6 35 U.S.C. § 103(b)," 1184 O.G. 86 (March 26, 1996). Additionally, in order
to retain the right to rejoinder in accordance with the above policy, Applicant is advised
that the process claims should be amended during prosecution either to maintain
dependency on the product claims or to othenwise include the limitations of the product
claims. Failure to do so may result in a loss of the right to rejoinder.

Further, note that the prohibition against double patenting rejections of 35 U.S.C.
121 does not apply where the restriction requirement is withdrawn by the examiner
before the patent issues. See MPEP § 804.01 .

8. Any inquiry concerning this communication or earlier communications from the
examiner should be directed to Jeffrey Fredman whose telephone number is currently
703-308-6568. In mid January, 2004, when TC 1 600 relocates to the new USPTO

Application/Control Number: 09/581 ,402

Page 6

Art Unit: 1634

facility in Alexandria, the examiner's phone number will become 571-272-0742. The
examiner can normally be reached on 6:30-4:00.

If attempts to reach the examiner by telephone are unsuccessful, the examiner's
supervisor, Gary Benzion can be reached on 703-308-1 119. The supervisor's new
telephone number in mid January will be 571-272-0782. The fax phone number for the
organization where this application or proceeding is assigned is currently 703-872-9306.

Any inquiry of a general nature or relating to the status of this application or
proceeding should be directed to the receptionist whose telephone number is 703-308-
0196. ^-"■""''^

Jeffrey Fredman
Primary Examiner
Art Unit 1634